27 Jan 2020

Some university researchers still believe that if their clinical trial publishes its outcomes in a peer-reviewed journal, they do not also have to upload its summary results onto trial registries.

That is wrong. Here are the facts:

  • Both EU regulations and US law require the results of many (though not all) clinical trial results to be uploaded onto trial registries within 12...

27 Jan 2020

A new study has found that Polish academic medical centres have never published the results of 62 clinical trials involving over 13,000 patients.

In total, just over 20% of all trials sponsored or conducted by these Polish institutions have become research waste.

Failure to publish clinical trial results is unethical, scientifically unsound, and harms patients and public health....

23 Jan 2020

Cochrane Germany has issued a statement calling the failure by German universities to make clinical trial results public in line with European transparency rules "completely unacceptable".

The statement follows the release of a report by TranspariMED and BUKO Pharma-Kampagne in late December that showed that at least 477 clinical trials run by German universities were missing re...

22 Jan 2020

A new study has found that 1,523 clinical trials of medicines and medical devices have failed to make their results public on the United States database due to the FDA’s failure to enforce a key medical transparency law.

There is overwhelming evidence that hidden clinical trial results harm patients and undermine public health.

Nonetheless, the team of researchers from the Univer...

22 Jan 2020

A landmark ruling on access to information about medicines today upheld independent scientists’ access to detailed information on the effects and harms of drugs taken by patients across Europe.

The documents in question, Clinical Study Reports (CSRs), provide a highly detailed picture of the design, conduct, analysis and findings of clinical trials, including data on the positiv...

10 Jan 2020

Many German universities struggle to navigate the complexities of clinical trial reporting. This blog post discusses five common misconceptions, and suggests how universities can improve their performance.

But first some context:

Current university reporting performance is weak because there has been a diffusion of responsibilities within institutions and no clear oversight. In a...

7 Jan 2020

Europe’s largest medical association and a member of the European Parliament have urged German medicine regulators and universities to improve clinical trial reporting.

These calls for greater transparency come in the wake of a report showing that 445 clinical trials of medicines run by German universities are missing results on the European database EudraCT, in violation of lon...

5 Jan 2020

The UK Health Research Authority yet again seems poised to let patients down.

A document that appeared online in December suggests that the UK's medical research ethics regulator is determined to let clinical trial sponsors off the hook for failing to adhere to its own rules on clinical trial registration and reporting - defying the wishes of patients, parliament, and the wider...

29 Dec 2019

German universities have failed to make public the results of 445 clinical trials of medicines on a European database, in violation of European Union transparency rules, a report released today shows.

The outcomes of many of those trials remain completely unpublished and are in acute danger of becoming costly research waste.

German universities’ failure to adhere to scientific b...

19 Dec 2019

The UK government today announced plans to develop a

“streamlined, internationally competitive approach to the licensing and regulation of innovative medicines and devices, to give patients access to the best possible treatments and support the UK’s life sciences industry.”

Currently, most of the UK regulatory framework for drugs and devices is set by Brussels.

Post Brexit, depen...

19 Dec 2019

A lawsuit aiming to prevent the release of drug safety data threatens patients and public health across Europe, 31 patient and public health groups from across Europe warn in an open letter published today.

UPDATES January 2020:

30 Nov 2019

While universities in other countries are rapidly progressing in making their clinical trial results public, some universities in Germany still lag far behind.

Data from the EU Trials Tracker shows that the five worst performers in Europe are all German universities. Between them, these universities have sponsored 95 clinical trials that are due to post results onto the European...

22 Nov 2019

The Association of the British Pharmaceutical Industry (ABPI) identifies “high standards for transparency” as one of seven key factors required to maintain the UK’s position as an "attractive destination for global investment in the sector".

According to a new policy paper published by ABPI:

A key element of research transparency is registration and reporting on international da...

21 Nov 2019

Irish medical schools have made the results of over 85% of their clinical trials available on the European trial registry, making Irish universities the strongest transparency performers in the whole of Europe.

Irish universities’ reporting rate of 85.7% places it ahead of academic institutions in the UK, which have uploaded the results of 72.1% of their trials. In contrast, les...

8 Nov 2019

Failure to register and report clinical trials is not a victimless crime. It harms patients, undermines public health, slows down medical progress, and wastes public funds.

Nonetheless, not a single institution has ever been fined, anywhere in the world, for violating universally recognised ethical obligations.

During a recent parliamentary hearing in the UK, the issue of sanctio...

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